Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name polymer patient examination glove
510(k) Number K192954
Device Name Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
Applicant
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821, Jalan Matang
Matang,  MY 34750
Applicant Contact Ng Kok Howe
Correspondent
Comfort Rubber Gloves Industries Sdn. Bhd.
Lot 821, Jalan Matang
Matang,  MY 34750
Correspondent Contact Ng Kok Howe
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   QDO  
Date Received10/21/2019
Decision Date 06/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-